SwePub
Sök i LIBRIS databas

  Utökad sökning

WFRF:(Bergqvist L. L.)
 

Sökning: WFRF:(Bergqvist L. L.) > Major joint replace...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00003869naa a2200541 4500
001oai:gup.ub.gu.se/107031
003SwePub
008240528s2008 | |||||||||||000 ||eng|
0247 a https://gup.ub.gu.se/publication/1070312 URI
040 a (SwePub)gu
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Dahl, O. E.4 aut
2451 0a Major joint replacement. A model for antithrombotic drug development: from proof-of-concept to clinical use
264 1c 2008
520 a AIM: Development of antithrombotic compounds has traditionally been performed in patients undergoing total hip and knee replacement surgery. A high number of asymptomatic deep-vein thromboses are radiologically detectable, and bleeding and other adverse events (AE) are easy to observe. However, standardization of study procedures and endpoints in early proof-of-concept studies and late pure clinical endpoint studies has been lacking. This has made comparison between studies difficult, economic analyses speculative and potential benefits of applying the drug regimen in non-selected patients uncertain. In this paper, the International Surgical Thrombosis Forum proposes a strategy for the clinical investigation of new pharmacological agents for the prophylaxis of postoperative thrombotic events. METHODS: First, dose titration safety studies of short duration, in highly selected patients using objective venographic endpoints are recommended. Bleeding should be divided into the quantified volume of surgical bleeding and other adjudicated clinical bleeding events. The number of AE should be described for each dose step and classified according to International Coding of Diagnoses (ICD). Second, a dose confirmatory study of moderate exposure period and sufficient follow-up time is recommended. The exclusion criteria should be restricted to contraindications of the compared drugs and technical procedure. RESULTS: The efficacy, bleeding and AE should be similar to those used in dose-titration studies. In addition, the failure rate of the drug to exert its effect and the net clinical benefit should be calculated. CONCLUSION: Finally, trials with simple clinical endpoints and long follow-up should be conducted to evaluate the potential benefits of the drug-regimen in non-selected populations.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kirurgi0 (SwePub)302122 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Surgery0 (SwePub)302122 hsv//eng
653 a *Arthroplasty
653 a Replacement
653 a Clinical Protocols
653 a Dose-Response Relationship
653 a Drug
653 a Drug Evaluation/*methods
653 a Fibrinolytic Agents/*administration & dosage
653 a Humans
653 a Postoperative Complications/*prevention & control
653 a Thromboembolism/prevention & control
653 a Venous Thrombosis/*prevention & control
7001 a Borris, L. C.4 aut
7001 a Bergqvist, D.4 aut
7001 a Schnack Rasmussen, M.4 aut
7001 a Eriksson, Bengt I.,d 1946u Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences4 aut0 (Swepub:gu)xerben
7001 a Kakkar, A. K.4 aut
7001 a Colwell, C. W.4 aut
7001 a Caprini, J. A.4 aut
7001 a Fletcher, J.4 aut
7001 a Friedman, R. J.4 aut
7001 a Lassen, M. R.4 aut
7001 a Frostick, S. P.4 aut
7001 a Sakon, M.4 aut
7001 a Kwong, L. M.4 aut
7001 a Kakkar, V. V.4 aut
7102 a Göteborgs universitetb Institutionen för kliniska vetenskaper4 org
7730 t International angiologyg 27:1, s. 60-7q 27:1<60-7x 0392-9590
8564 8u https://gup.ub.gu.se/publication/107031

Hitta via bibliotek

Till lärosätets databas

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

 
pil uppåt Stäng

Kopiera och spara länken för att återkomma till aktuell vy